Randomized Controlled Clinical Study To Evaluate The Efficacy Of Pugadi Kseera Seka In Vataja Charmadala w.s.r To Atopic Dermatitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Seka(Affusion Sudation) Will help in reducing symptoms of Atopic Dermatitis(Vataja Charmadala)
Study Overview
Brief Summary
Children are easily prone for skindiseases as they have thinner and delicate skin than adults and also due totheir sensitive immune system. In pediatric practice, one third of the patientscome with complaints of skin diseases, Atopic dermatitis being the most commonamong the dermatological condition of infancy and early childhood. It is achronic, inflammatory relapsing skin disorder with varying degree of pruritusand inflammation of skin accompanied by cutaneous physiological dysfunction
It affectsthe estimated 1-5% of world population, more than 10-20% of children less than14 years of age. The prevalence of Atopic dermatitis has beenincreasing over the past few decades in industrialized and developing countriesincluding India especially in younger children .The incidence of Atopicdermatitis is more in children residing in Bangalore which is also the allergycapital of the country because of the increased pollution, dry weather, urbanizationetc.
Social stigma of living with a visible skin condition likeAtopic dermatitis affects a child’s social and mental well being, in turnaffecting his growth in all dimensions. In modern science there is no specificand effective treatment modality for Atopic dermatitis. Topical steroidsapplications, anti histamines and moisturizers are commonly used, which makesskin sensitive on regular usage and leads to flaring up of symptoms ondiscontinuation of treatment. So there is a need to find an effective line ofmanagement for this condition.
Amongthe different modalities of treatment mentioned for Vataja charmadalalike Pradeha, Lepa, Seka, Abhyanga etc, the effectof Lepa in Vataja Charmadala has been analysed throughseveral studies. But only few studiesare carried out to analyse the effect of Seka (affusion sudation), atype of Drava Sweda in this condition*.* Hence this study is aneffort made to assess the efficacy of Pugadi ksheera sekaand Pancha tiktaka gritha lepa in Vataja charmadala.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Year(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects of age group 1 year to 5 years will be included irrespective of religion, gender and socio-economic status.
- •Subjects diagnosed with Lakshanas of Vataja charmadala will be included for the study.
- •Subjects having the clinical features of acute & subacute atopic dermatitis will be included.
Exclusion Criteria
- •Subjects below the age of 1 year and above the age of 5 years will be excluded.
- •Chronic atopic dermatitis (more than 1 year duration) will be excluded.
- •Atopic dermatitis associated with secondary bacterial infection, lichenification, oozing from the site of lesion will be excluded.
- •Subjects presenting any other associated systemic symptoms like diarrhoea, acute respiratory infections, acute febrile conditions will be excluded.
Outcomes
Primary Outcomes
Seka(Affusion Sudation) Will help in reducing symptoms of Atopic Dermatitis(Vataja Charmadala)
Time Frame: 7 Days
Secondary Outcomes
- Panchatikta Ghrita Lepa will have less effect than Pugadi Ksheera Seka in Atopic Dermatitis(7 Days)